Label: CETIRIZINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-709-10, 21695-709-14, 21695-709-20, 21695-709-30 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0781-1684
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 9, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep out of reach of children
- Uses
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Warnings
Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
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Directions
adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor - Inactive ingredients
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Principal Display Panel
NDC 21695-709-10 Bottle of 10
NDC 21695-709-14 Bottle of 14
NDC 21695-709-20 Bottle of 20
NDC 21695-709-30 Bottle of 30
Cetirizine HCl Tablets
10 mg
antihistamine
Do not use if individual blister unit is open or torn
ALLERGY
Indoor & Outdoor Allergies
24 hour Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-709(NDC:0781-1684) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (round shape) Size 8mm Flavor Imprint Code SZ;906 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-709-14 14 in 1 BOTTLE 2 NDC:21695-709-20 20 in 1 BOTTLE 3 NDC:21695-709-30 30 in 1 BOTTLE 4 NDC:21695-709-10 10 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077946 12/27/2007 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK